President Forms New Bioethics Committee

Press Release Here.

So far, he appointed Dr. Amy Gutman, President of U of Penn, and Dr. James Wagner, President of Emory University. In a home town connection, Dr. Wagner once served as Provost, University Vice President, and Interim President of Case Western Reserve University. Prior to that, he was Dean and Professor of Materials Science at the Case School of Engineering from 1998 to 2000.

According to The Philadelphia Inquirer, the panel "replaces President George W. Bush's Council on Bioethics, which drew criticism in scientific circles over alleged bias."

One such incident refers to the firing of Nobel-laureate Elizabeth Blackburn, as she writes about in the New England Journal of Medicine found here.

Three of the 18 members of the original bioethics council were full-time biomedical research scientists. Chairman Leon Kass, of the University of Chicago, has, in his published work, questioned modern medical and biomedical science and taken the stance of a "moral philosopher," often invoking a "wisdom of repugnance" — in other words, rejecting science, such as research involving embryonic stem cells, because it feels wrong to him.

Work with animal models has been indicating the potential benefits of research involving embryonic stem cells for more than two decades...such research may result in therapies for diabetes, Parkinson's disease, and spinal injuries, among other conditions. Yet the best possible scientific information was not incorporated and communicated clearly in the council's report [Report on Monitoring Stem Cell Research], suggesting that the presentation was biased.

Adam Holland explains: In spite of statutory requirements for appointing a panel with a balanced constituency representing a diversity of opinion, Bush replaced Blackburn and her colleague Dr. William May with Dr. Ben Carson, Diana Schaub and Peter Lawler, all of whom had passed litmus tests regarding stem cell research and other issues. The Bush-nominated panel, already stacked with non-scientists who supported his views, was thus denied the input of independent scientific voices on this question.

Union of Concerned Scientists piped up, and OMB watch was unamused.

While this incident is important, it also encourages a misperception that the field of bioethics is only about stem cell research or cloning, and bioethicists are only scientists or researchers. Those who specialize in bioethics have degrees in law, medicine, philosophy, religion, psychology, economics, etc. and their role is more likely to serve as the 'conscience' of an organization as opposed to the usual 'money-driven' or 'lawsuit-avoidance' approach we're familiar with. It's a need to find a balance between pragmatism and ideaology; profit and humanity.

In the next three years the President's Council could deliver guidance on reproductive issues (IVF, surrogacy), end-of-life decisions (DNR, etc), medical errors and how they're handled, clinical research guidelines involving human subjects, controversial and new medical technologies (gastic bypass, brain surgery to treat severe obsessive-compulsive disorder), and transplant issues (protection and selection of living donors, preventing organ failure, and coping with the inevitable shortage of donor organs), issues that affect all of us in some way. The choices of Wagner and Gutman are important - and consequently, so are their future policy suggestions.

Stay tuned....

You Want Cheerleaders, Go to a Football Game

One of the interesting aspects of the internet and social networks is that it enables folks to reconnect with other folks they last recall tumbling off the merry-go-round on the school playground. Sometimes, it unwittingly puts us in a collision course with our (or others') misconceptions.

For example:

Hi Cristy!!! I have a co-worker whose husband is in need of a kidney donor. Do you have any suggestions or advice.

I considered my reply for about 24-hours. In virtual land, that's not an unreasonable time lag, but it wasn't as if I just 'didn't get around to it', I was actually thinking about what to say.

I'm certainly not the person to ask about soliciting strangers (and otherwise) to pony up a kidney. My advice to any prospective recipient is to educate themslelves about what they're asking someone to do. There's an erroneous perception, encouraged by the transplant centers, that it's 'safe' to be a living donor, with no short-term or long-term risks, which is really, really not the case. Aside from the obvious (and maybe not-so-obvious; refer to www.livingdonor101.com/risks.shtml), some living donors suffer from depression, anxiety, anger and PTSD (and there are no resources for them), some experience financial hardship, and some are unable to find health insurance post-donation. And even if a living donor has insurance, some insurance companies are refusing coverage for things like hypertension - even it shows up ten or more years later - as 'related' to the donation. I think it's crucially important that a would-be recipient ask themselves if they'd be willing to take on those risks (not to mention the permanent compromising of their bodies) for someone, especially a non-relative. If not, it's unethical for them to ask it of someone else.

Because the living donors that talk to the media are 95% what I refer to as 'happy' donors (or in my more cynical moments, 'martyr' donors), there is the idea that all living donors are recruiters for the 'club'. Some people find it shocking to realize that some living donors believe the decision to be a personal one, complicated by the tundra of misinformation and pressure to 'save a life' or be a 'hero'. Many of us understand how deficient the system is, how one-sided the policies are, and we are reluctant to be complicit in bringing someone else into the fold.

Transplant centers have begun encouraging would-be recipients to solicit potential living donors. Not only is this a disingenous way for transplant centers to keep their hands clean of 'brokering' but still rake in the revenue of the procedures and evaluations, it's unfair to the recipients and their loved ones. They are not told the reality of living donation as I've detailed above; only the sanitized version that ONE study at ONE center (with a 40% non-respondent rate) says living donors don't croak any sooner than non-donors (really? that's what passes for good research data these days?). They mislead these people into believing that what they're asking someone to do is not only ethical, it is medically and psychosocially safe.

Not surprisingly, I haven't heard from this person again. I have an inkling she didn't pass on my comments to her co-worker either. So, in some small way, she has just potentially played a part in permanently maiming* a healthy person to - not cure someone, because transplants are not cures - but just maybe, perhaps, improve someone's quality of life. But think of it this way, if the kidney fails, the recipient can find another. A living donor however, remains wounded for life.




*according to dr. art caplan, 2009 UN report on organ trafficking.

UPMC's Hamar Clouds Truth of Living Donation

http://www.pittsburghlive.com/x/pittsburghtrib/news/pittsburgh/s_651813.html

In a recent interview, Dr. Abhinav Humar, University of Pittsburgh Medical Center’s transplant chief stated his intention to increase the use of organs from the living to over 60%. While his motivation to help those with liver and kidney disease should be lauded, it should not come at the expense of another group of healthy people – namely, Live Donors.

Dr. Human is quoted as saying “The live-donor kidney transplant poses few complications for the…donor”. This is a purposely misleading, if not completely disingenuous distortion of the facts.

The Living Organ Donor Network found:

- Post-operative and wound healing complication rate of 23.07%.
- 37.5% complication rate only ONE YEAR post-donation. (Many health-related issues, such as hypertension or severely reduced kidney function will not appear for many years, so this number will only increase.)

The first living kidney donor transplant occurred in 1954, but until 2000, the medical community severed ties with Live Donors upon their hospital discharge. Even now, transplant centers are only required to submit the most basic follow-up form for two years, and the examination is done by the Live Donor’s primary care physician and not the original surgeon or nephrologist.

Dr. Humar, like many transplant surgeons and Live Donor Proponents, is deliberately manipulating the truth, utilizing the lack of comprehensive data regarding Live Donors’ health and well-being as proof that physically and permanently compromising a person by removing an essential organ is ‘safe’. Absence of proof is not proof of absence.

Dr. Humar is also quoted as saying, “Surgeons…can limit [complications] by following regimented procedures, carefully screening patients and preparing for problems that occur.”

Except, they don’t. Instead of ‘regimenting’ procedures to minimize risk to Live Donors, transplant centers across the U.S. have been broadening their criteria to include people previously deemed unacceptable due to age or a health-related concern (hypertension, obesity, etc). Worse, they are given almost total discretion over their evaluation and care procedures, so there are no concrete standards, quality control, nor punitive measures to be taken for incompetency.

Informed Consent requires that prospective Live Donors be FULLY informed of the risks of live donation, yet they are regularly not told about the nearly 200 live kidney donors since 1993 that have needed their own transplant, nor are they informed of the risk of vascular injuries (renal artery, renal vein, aorta, common iliac artery, vena cava and mesenteric veins), bowel injuries, spleen laceration, liver laceration, pneumothorax, diaphragm injury, cardiac arrhythmias, urethral strictures, atrial fibrillation, small bowel obstruction requiring return to the OR, sepsis, respiratory distress, pneumonia, retroperitoneal hematomas, hernias, testicular swelling, adrenal gland dysfunction, nerve damage, hypertension, adrenal gland dysfunction, lymph leakage, and severely reduced kidney function.

It is also known that Live Donors suffer from depression, anxiety, anger and PTSD, yet transplant centers offer no mental health or supportive aftercare services. Even though a 1972 Medicare benefit exists to cover all Live Donor-related expenses, transplant centers and CMS violate the law by seeking reimbursement from the recipient’s insurance, resulting in the Live Donor paying out-of-pocket for any mental health services needed.

If Dr. Hamar and the transplant professionals at UPMC are such proponents for Live Donation, I suggest they begin by having themselves tested as prospective kidney and liver donors. Their first-hand knowledge of the Live Donor process will not only prove invaluable to their patients, and it will instill the public’s confidence. After all, there is no substitute for leading by example.

Why Everything Sucks

Misinformation and Mixed Message from Someone Who Should Know Better

http://www.nephronline.com/features.asp?F_ID=479

At the above link, Dr. Cooper, a transplant surgeon in Maryland and the head of the OPTN Living Donor Committee, waxes poetic on why living donation rates have decreased over the past five years, citing barriers such as out-of-pocket expenses and insurance issues.

His first error, however resides in this statement:

no coverage exists beyond three to six months from donation even for conditions that may be related to the donation.

Wrong. 42 USC 1399 rr, aka the Social Security Act 1881, passed in 1972 gave living donors a Medicare benefit, to whit:

Any individual who donates a kidney for transplant surgery shall be entitled to benefits... Reimbursement for the reasonable expenses incurred by such an individual with respect to a kidney donation shall be made...for all reasonable preparatory, operation, and post-operation recovery expenses associated with such donation... Payments for post-operation recovery expenses shall be limited to the actual period of recovery.

However, in 1974, the director of the SSA insisted that transplant centers send all living donor-related bills to a recipient's insurance (gotta keep those Medicare costs down). Since private insurance provides a much higher reimbursement than Medicare, transplant centers happily complied. Meanwhile, living donors are unaware of this benefit, and people like Dr. Cooper perpetuate the misnomer that it doesn't exist, creating the very barriers he's now protesting against.

Dr. Cooper then praises the National Kidney Foundation's "end the wait!" initiative for addressing these problems, displaying its recommendations as examples:

- improve the outcomes of first transplants
- increase deceased donation
- make the donation system and processes more efficient and equitable, and increase living donation.

I've read and re-read these objectives multiple times and nowhere do I see anything that benefits living donors. Nothing about a living donor registry to FINALLY begin compiling comprehensive data on living donors to determine the true long-term effects; Nothing about improving Informed Consent; Nothing about mental health services; Nothing about aftercare. Dr. Cooper spends an entire essay trying to convince the reader that the safety and care of living donors are his first priority when his admiration of NKF's goals reveals the wolf beneath the wool cloak, the man behind the curtain, and the true lizard countenance of the Visitors - like so many of his counterparts (including NKF), his primary concern is really about procuring more organs for would-be recipients, and coincidentally (or not) generating more revenue for his transplant center. This revelation is contradictory considering Dr. Cooper's position with OPTN, and worse, disappointing to those of us trusted him to do the right thing.

Definition of Succes, tranplant style

http://www.ajc.com/opinion/system-punishes-organ-donors-189025.html

The above link is a short editorial from a living donor waxing poetic about insurance comapnies' tendency to deny living donors care and coverage due to a 'pre-existing condition'.

The very end of the editorial says:

Kathie McClure, an Atlanta attorney and the founder of VoteHealthcare.org, successfully donated a kidney to Dan Krinsky in August.


Sucessful for whom? Mr. Krinsky, who is apparently recovering well, or successful for the surgeons and transplant center because they managed not to maim Ms. McClure during the procedure?

Ms. McClure is now at a higher risk for hypertension, cardiac problems, and severely reduced kidney function, kidney disease and kidney failure due to her donation. She may suffer from depression, anxiety and PTSD as a result of her experience.

The problem is that everyone in regards to transplants are framed in terms of the recipient. If the graft sticks and the recipient is discharged, the process is deemed a success. No one considered the fate of the donor, immediately, short-term or (even worse) long-term. Hell, UNOS loses 40 of living donors 6 months post-surgery; we have no idea what happens to these people, and the transplant centers distance themselves from living donors as soon as possible, providing no aftercare and siphoning them off on their primary care physicians.

Daniel Huffman donated a kidney to his grandmother when he was 17 years old. He put a bullet in head a few years later. Everyone considered his donation to be 'successful' too.

Kidney Donor Billed For Complications - & He's Not the Only One

http://www.statesman.com/news/content/news/stories/local/2009/11/01/1101donors.html

(read the whole article; below are excerpts)

Knisely, a 53-year-old tax analyst for the state comptroller's office, has received numerous notices that his insurance company was billed thousands of dollars by the hospital, doctors and other medical providers for treatment of post-surgery complications such as pancreatitis, an inflammation of the pancreas. Knisely said he also has been billed directly several times and has been contacted by a collection agency because he wouldn't pay.

Kimberly Tracy, a 51-year-old dialysis nurse who lives in Dayton, Ohio, donated a kidney to her nephew in 2001 and said she had to provide her insurance information to the hospital to get pain medication from the surgery.

"It was either that, or I was going to have to suck it up and go home without any," she said. She ended up using her own insurance to pay for the medicine and other transplant-related bills, including a later surgery, she said.

Knisely said the hospital did not tell him that if ever he loses his insurance with the state comptroller's office where he and Vara, 52, work, some insurers might consider a single kidney to be a pre-existing condition and a possible reason to deny future coverage.

Laura Odom, a 52-year-old mother of five in Wheaton, Ill., said after she donated part of her liver in 2002 to her sister-in-law, who had liver disease, she was billed incorrectly for the transplant and for treatment for later complications. She said it took about six months to straighten out the billing, but she's had ongoing health problems since the transplant, including chronic pain and a grapefruit-sized hernia in her diaphragm that led to serious intestinal problems.

She can no longer get private insurance because she is considered to have a pre-existing medical condition, she said. She is on Medicaid now.

Everything was done so hurriedly to save her sister-in-law, she said, that she didn't know that in the process of donating part of her liver doctors also would have to remove her gallbladder. That has contributed to her digestive problems, Odom said.

"In retrospect, I would have done things differently. I would have had a notebook and gotten things in writing," Odom said. "I have a recipient who has her life back, and now I'm sicker than she is."